Intimate Partner ViolenceNCT05856214
Effect of Couple Based Violence Prevention Education on Intimate Partner Violence During Pregnancy in Southern, Ethiopia
A study testing Couple-Based Violence Prevention education(CBVPE) in people with Intimate Partner Violence, run by Jimma University at 1 site in Ethiopia.
Trial summary
A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy(IPVp), which has adverse maternal and newborn outcomes. Intervention addressing their intimate partners are not well-studied, particularly in Ethiopian setting. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Couple-Based Violence Prevention education(CBVPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Coupe whose wife is pregnant (trimester)
- Couple whose wife has at least one live birth
- Couple who lived in the study area at least six months before the study
- Couple whose wife's inter-pregnancy interval is less than two years
- Couple willing to be visited at home
Who cannot join
- Couple having a severe medical illness
- Couple with hearing or communication problems
- Couple with a plan to move out from the intervention and control clusters in the next 8 months
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
1st Benara Health post
Hosa’ina, Central Ethiopia/Hadiya Zone
Tereza Petros, BSc Nurse, +251937252247
About this study
Official title: Effect of Couple-Based Violence Prevention Education on Intimate Partner Violence in Hadiya Zone, Southwest Ethiopia
A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy(IPVp), which has adverse maternal and newborn outcomes. Intervention addressing their intimate partners are not well-studied, particularly in Ethiopian setting. The investigators use a cluster randomized control study to evaluate the effectiveness of Couple-Based Violence Prevention Education(CBVPE). CBVPE is an intervention aimed to improve experience of violence during pregnancy, male partners knowledge, attitudes and controlling behavior towards intimate partner violacein this study kebeles found under each districts will be used as clusters. Sixteen clusters will be randomly assigned into one of two arms, each comprised of 216 couples. A total of 864 participants (432 pregnant women and 432 their male partners will be recruited for the study. women in the control group will receive the usual care provided by Health Extension Workers(HEWs), which is routine care. The intervention arm, wife and husband will be exposed to CBVPE that explores maternal health, intimate partner violence, adverse effects of violence during pregnancy, triggers of IPV, managing triggers of IPV, problem solving skills and health relationship. Our hypothesis is that CBVPE is superior to routine care in reducing and /or controlling intimate partner violence during pregnancy in HadiyaZone, Southwest Ethiopia. Structured interviewer administered questionnaire will be used to collect data at base-line and end-line.
Read the detailed description
Violence during pregnancy is a possible risk to not only the pregnant mother but also the risk to that unborn child. IPV during pregnancy is associated with adverse maternal outcomes including emotional distress, depression, anxiety, insufficient or inconsistent prenatal care, inadequate gestational weight gain, higher rates of smoking, alcohol use, and mortality. In Ethiopia, intimate partner violence is one of the hidden epidemics, that needs appropriate intervention strategy. Couples in intervention arm 1 will be exposed to CBVPE, which explores intimate partner violence, consequences of violence during pregnancy, common triggers of IPV during pregnancy, the role of male partners in pregnancy, healthy relationships, and problem-solving skills. Couples in control arm 2, will receive the usual care provided by the Health Extension Workers. Our hypothesis is that women in intervention arm 1 will report less experience of intimate partner violence than participants in arm 2, the control group. Data will be collected at baseline and end line using a structured questionnaire. The study has the following specific objectives
- To evaluate the effect of couple-based violence prevention education on male partners' knowledge, attitudes, and controlling behavior towards IPV during pregnancy
- To compare the effect of couple-based violence prevention education on the experience of IPV during pregnancy
- To Compare the effect of couple-based violence prevention education on women's autonomy and self-efficacy
- Conditions
- Intimate Partner Violence
- Being tested
- Couple-Based Violence Prevention education(CBVPE)
- Keywords
- Intimate partner violence, Hadiya zone, Southwest Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-Based Violence Prevention education(CBVPE)Behavioural
Couples in the intervention group will receive training on violence against women including intimate partner violence, types, and consequences of intimate partner violence during pregnancy, managing triggers of intimate partner violence, healthy relationships, the role of male partners during pregnancy, and couples communication and problem-solving skills. Training will be provided every fourth week by trained health extension workers for consecutive six months.
| Study group | Role | What they receive |
|---|---|---|
| Couple-based violence prevention education(CBVPE) | Experimental | Couples in the intervention group will receive trainings on gender based violence, intimate partner violence, Consequences of violence during pregnancy, common triggers of intimate partner violence, a healthy relationship in marriage ,couples communication and conflict management Receives: Behavioral: Couple-Based Violence Prevention education(CBVPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the proportion of women who experience intimate partner violence during pregnancy
WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire is adapted to assess intimate partner violence (IPV).
Physical violence: the intentional use of physical forces by the husband (Slap, push, shove or pull hair, kick, drag or beat, attempt to choke or burn on purpose, threaten to use or actually use a gun, knife, or another weapon) Sexual violence: when a husband forces his wife to have sexual intercourse with him when she doesn't want to, forces her with threats, in any other way to perform sexual acts she does not want, and/or physically forces her to perform any other sexual acts she does not want to Psychological violence: when the husband says or does something to humiliate his wife in front of another person and /or threatens to hurt or harm someone she cares about and/or insult or make her feel bad about herself. IPV is when the woman experiences any physical and/or sexual and/or psychological violence in combination during pregnancy
Measured: 8 months
Secondary outcomes (1)
The difference in the proportion of couples' attitudes, and husband's controlling behavior(AC) toward intimate partner violence
WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire is adapted to assess couples' attitudes towards IPV during pregnancy. Couples will be asked whether a husband is justified in hitting or beating his wife in 5 scenarios: If the wife goes out without telling the husband, if the wife neglects the children, if the wife argues with the husband if the wife refuses to have sex with husband, and if she burns the food. The response will be coded as '1' if the participant agrees with at least one attitude question, otherwise will be coded as '0' Couples will be asked six controlling questions. If the husband: is jealous if she talks with other men, accuses her of unfaithfulness, does not permit her to meet her friends, tries to limit her contact with family, insists on knowing where she is, and does not trust her with money. Couples who responded "yes" to one or more of the control questions will be coded as 1. Otherwise, it will be coded 'no' as 0.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Aug 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment: intervention group vs Control group
- Masking
- None (open label)
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Wachemo University
- Responsible party
- Principal investigator, Zeleke Dutamo, Jimma University
- Investigators
- Zeleke D Agde, MPH, Principal investigator, Department of population and family studies, Institute of Health, Jimma University, EthiopiaMuluemebet A Wordofa, professor, Study chair, Department of population and family studies, Institute of health, Jimma University, EthiopiaNega A Kassa, Professor, Study director, College of Medical and Health Sciences, Haramaya University, EthiopiaJeanette H Magnus, Professor, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856214
- Sponsor's protocol ID
- Couple-Based Education
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data(IPD) will be shared
Publications
Agde ZD, Tirore LL, Abdissa HG, Abageda M, Agafari GB, Magnus JH, Assefa N, Wordofa MA. Effectiveness of community-based health education intervention on knowledge, attitudes, and controlling behaviors related to intimate partner violence in Hadiya Zone, Central Ethiopia: a cluster randomized controlled trial. BMC Womens Health. 2026 May 1;26(1):310. doi: 10.1186/s12905-026-04507-x.
PubMed 42067864Agde ZD, Magnus JH, Assefa N, Wordofa MA. Effects of couple-based violence prevention education on male partners' knowledge, attitudes and controlling behavior related to intimate partner violence in rural Ethiopia: a cluster randomized controlled trial. Front Public Health. 2025 Mar 10;13:1506459. doi: 10.3389/fpubh.2025.1506459. eCollection 2025.
PubMed 40129596Agde ZD, Magnus JH, Assefa N, Wordofa MA. Effectiveness of couple-based violence prevention education in reducing intimate partner violence during pregnancy in rural Ethiopia: A cluster randomized controlled trial. PLoS One. 2025 Jan 17;20(1):e0317667. doi: 10.1371/journal.pone.0317667. eCollection 2025.
PubMed 39823488Agde ZD, H Magnus J, Assefa N, Wordofa MA. The protocol for a cluster randomized controlled trial to evaluate couple-based violence prevention education and its ability to reduce intimate partner violence during pregnancy in Southwest Ethiopia. PLoS One. 2024 May 13;19(5):e0303009. doi: 10.1371/journal.pone.0303009. eCollection 2024.
PubMed 38739581
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Couple-Based Violence Prevention Education on Intimate Partner Violence in Hadiya Zone, Southwest Ethiopia
- ClinicalTrials.gov ID
- NCT05856214
- Acronym / sponsor ID
- Couple-Based Education
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate partner violence, Hadiya zone, Southwest Ethiopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Wachemo University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy(IPVp), which has adverse maternal and newborn outcomes. Intervention addressing their intimate partners are not well-studied, particularly in Ethiopian setting. The investigators use a cluster randomized control study to evaluate the effectiveness of Couple-Based Violence Prevention Education(CBVPE). CBVPE is an intervention aimed to improve experience of violence during pregnancy, male partners knowledge, attitudes and controlling behavior towards intimate partner violacein this study kebeles found under each districts will be used as clusters. Sixteen clusters will be randomly assigned into one of two arms, each comprised of 216 couples. A total of 864 participants (432 pregnant women and 432 their male partners will be recruited for the study. women in the control group will receive the usual care provided by Health Extension Workers(HEWs), which is routine care. The intervention arm, wife and husband will be exposed to CBVPE that explores maternal health, intimate partner violence, adverse effects of violence during pregnancy, triggers of IPV, managing triggers of IPV, problem solving skills and health relationship. Our hypothesis is that CBVPE is superior to routine care in reducing and /or controlling intimate partner violence during pregnancy in HadiyaZone, Southwest Ethiopia. Structured interviewer administered questionnaire will be used to collect data at base-line and end-line.
Detailed description
Violence during pregnancy is a possible risk to not only the pregnant mother but also the risk to that unborn child. IPV during pregnancy is associated with adverse maternal outcomes including emotional distress, depression, anxiety, insufficient or inconsistent prenatal care, inadequate gestational weight gain, higher rates of smoking, alcohol use, and mortality. In Ethiopia, intimate partner violence is one of the hidden epidemics, that needs appropriate intervention strategy. Couples in intervention arm 1 will be exposed to CBVPE, which explores intimate partner violence, consequences of violence during pregnancy, common triggers of IPV during pregnancy, the role of male partners in pregnancy, healthy relationships, and problem-solving skills. Couples in control arm 2, will receive the usual care provided by the Health Extension Workers. Our hypothesis is that women in intervention arm 1 will report less experience of intimate partner violence than participants in arm 2, the control group. Data will be collected at baseline and end line using a structured questionnaire. The study has the following specific objectives
- To evaluate the effect of couple-based violence prevention education on male partners' knowledge, attitudes, and controlling behavior towards IPV during pregnancy
- To compare the effect of couple-based violence prevention education on the experience of IPV during pregnancy
- To Compare the effect of couple-based violence prevention education on women's autonomy and self-efficacy
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment: intervention group vs Control group
| Arm | Type | Receives |
|---|---|---|
| Couple-based violence prevention education(CBVPE) | Experimental | Behavioral: Couple-Based Violence Prevention education(CBVPE)Couples in the intervention group will receive trainings on gender based violence, intimate partner violence, Consequences of violence during pregnancy, common triggers of intimate partner violence, a healthy relationship in marriage ,couples communication and conflict management |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Coupe whose wife is pregnant (trimester)
- Couple whose wife has at least one live birth
- Couple who lived in the study area at least six months before the study
- Couple whose wife's inter-pregnancy interval is less than two years
- Couple willing to be visited at home
Key exclusion criteria (3 listed)
- Couple having a severe medical illness
- Couple with hearing or communication problems
- Couple with a plan to move out from the intervention and control clusters in the next 8 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-Based Violence Prevention education(CBVPE)Couples in the intervention group will receive training on violence against women including intimate partner violence, types, and consequences of intimate partner violence during pregnancy, managing triggers of intimate partner violence, healthy relationships, the role of male partners during pregnancy, and couples communication and problem-solving skills. Training will be provided every fourth week by trained health extension workers for consecutive six months. | Behavioural | Couple-based violence prevention education(CBVPE) |
Primary outcome
The difference in the proportion of women who experience intimate partner violence during pregnancy
Time frame: 8 months
WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire is adapted to assess intimate partner violence (IPV). Physical violence: the intentional use of physical forces by the husband (Slap, push, shove or pull hair, kick, drag or beat, attempt to choke or burn on purpose, threaten to use or actually use a gun, knife, or another weapon) Sexual violence: when a husband forces his wife to have sexual intercourse with him when she doesn't want to, forces her with threats, in any other way to perform sexual acts she does not want, and/or physically forces her to perform any other sexual acts she does not want to Psychological violence: when the husband says or does something to humiliate his wife in front of another person and /or threatens to hurt or harm someone she cares about and/or insult or make her feel bad about herself. IPV is when the woman experiences any physical and/or sexual and/or psychological violence in combination during pregnancy
1 secondary outcome
The difference in the proportion of couples' attitudes, and husband's controlling behavior(AC) toward intimate partner violence
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 42067864Agde ZD, Tirore LL, Abdissa HG, Abageda M, Agafari GB, Magnus JH, Assefa N, Wordofa MA. Effectiveness of community-based health education intervention on knowledge, attitudes, and controlling behaviors related to intimate partner violence in Hadiya Zone, Central Ethiopia: a cluster randomized controlled trial. BMC Womens Health. 2026 May 1;26(1):310. doi: 10.1186/s12905-026-04507-x.
- Derived from this study: PubMed 40129596Agde ZD, Magnus JH, Assefa N, Wordofa MA. Effects of couple-based violence prevention education on male partners' knowledge, attitudes and controlling behavior related to intimate partner violence in rural Ethiopia: a cluster randomized controlled trial. Front Public Health. 2025 Mar 10;13:1506459. doi: 10.3389/fpubh.2025.1506459. eCollection 2025.
- Derived from this study: PubMed 39823488Agde ZD, Magnus JH, Assefa N, Wordofa MA. Effectiveness of couple-based violence prevention education in reducing intimate partner violence during pregnancy in rural Ethiopia: A cluster randomized controlled trial. PLoS One. 2025 Jan 17;20(1):e0317667. doi: 10.1371/journal.pone.0317667. eCollection 2025.
- Derived from this study: PubMed 38739581Agde ZD, H Magnus J, Assefa N, Wordofa MA. The protocol for a cluster randomized controlled trial to evaluate couple-based violence prevention education and its ability to reduce intimate partner violence during pregnancy in Southwest Ethiopia. PLoS One. 2024 May 13;19(5):e0303009. doi: 10.1371/journal.pone.0303009. eCollection 2024.
- Individual participant dataSharing planned: Yes. All collected individual participant data(IPD) will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeleke D Agde, MPH principal investigator
Department of population and family studies, Institute of Health, Jimma University, Ethiopia
Muluemebet A Wordofa, professor study chair
Department of population and family studies, Institute of health, Jimma University, Ethiopia
Nega A Kassa, Professor study director
College of Medical and Health Sciences, Haramaya University, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-Based Violence Prevention education(CBVPE) in people with Intimate Partner Violence, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeleke D Agde, MPH (+251910489741, zeledutamo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the proportion of women who experience intimate partner violence during pregnancy (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05856214, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.